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Teknova completes FDA notification process for COVID-19 transport media

publication date: Oct 30, 2020
 | 
author/source: Teknova

teknova-completes-fda-notification-process-covid19


Teknova, a leading manufacturer of cell culture media and supplements, protein purification buffers, and molecular biology reagents, has completed the United States Food and Drug Administration (FDA) notification process for its CDC formulation Viral Transport Medium (VTM). Therefore, Teknova Viral Transport Medium is in compliance with the FDA’s COVID-19 Transport Media Policy, July 2020 guidelines. Teknova is now offering the validated Teknova Viral Transport Medium for commercial distribution.

As the COVID-19 pandemic took hold, and with a sudden and ongoing need for millions of SARS-CoV-2 tests, there was a significantly increased requirement for approved media to maintain virus viability from sample collection to the laboratory. Teknova responded immediately to this need, and within six months has set up and upscaled manufacturing for a new product, and also completed FDA notification for the product. The company currently has the capacity to manufacture 50,000 tubes of VTM a day, and is on track to produce more than 3 times that number of tubes daily over the coming months.

Throughout the manufacturing scale-up, Teknova has continued to put quality at the forefront. Teknova manufactures VTM and saline for sample transport under GMP conditions in compliance with ISO 13485 standards and the Quality System Regulations under 21 CFR Part 820. The company also performs additional bioburden testing to ensure product sterility.

“We are excited to have been able to go from zero production to FDA notification within six months and further contribute to combating COVID-19”, said Stephen Gunstream, Teknova’s CEO. “In March of this year, we had no idea we would be making viral transport medium; we hadn’t even thought about it. It has been an incredible effort to configure our manufacturing space; engineer, build, and install equipment; set up automation; and implement the formulation and quality control processes necessary to deliver this formulation of viral transport medium. We are pleased to be able to contribute to curbing this pandemic and returning our world to some form of normalcy.”

 

Learn more about Teknova VTM


 



 

 

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